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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-DuraSeal Exact Spine Sealant System


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General
Study Status Completed
Application Number P080013 / PAS001
Date Current Protocol Accepted 02/03/2016
Study Name OSB Lead-DuraSeal Exact Spine Sealant System
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: Estimate the rates of post-operative CSF leak, deep surgical site infection and neurological SAEs within 90 days for DuraSeal Exact Spine Sealant and to compare these rates to the corresponding rates for Control. Design: a multi-center, non-randomized, Post Approval study with a prospective treatment arm and a retrospective control arm.

Study Population Description For the retrospective controls (standard of care), subjects with fewer than 45 days of follow-up will be considered incomplete.

Sample Size The DuraSeal Exact Spine Sealant prospective treatment arm will enroll up to 489 subjects in order to obtain a total of 402 evaluable subjects with 90 day follow-up data.
Data Collection The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the spine surgical procedure.

A CSF leak is defined as a CSF fistula or a pseudomeningocele* confirmed by clinical examination or diagnostic testing (i.e., MRI or CT) whether or not treatment such as surgical repair or drainage is required.

* Pseudomeningocele noted on a diagnostic test must be confirmed by the study investigator

Secondary endpoints are the occurrence of the following events (within 90 days following the surgical procedure):

Deep Surgical Site Infections (DSSI) as defined per the CDC guidelines

All neurological SAEs



Follow-up Visits and Length of Follow-up For retrospective controls (standard of care), a patient will be considered completed if there is follow-up of at least 45 days.

New study sites that do not have 90 day standard of care visits will enroll prospective subjects only (DuraSeal and/or Control). This would allow new sites to contribute subjects prospectively inside the study window (60 to 120 days), and allow control over follow-up compliance.

Interim or Final Data Summary
Actual Number of Patients Enrolled 489 (treatment group) + 435 (control arm)
Actual Number of Sites Enrolled 36
Patient Follow-up Rate (429+406) / (489+435) * 100% = 90.4%
Final Safety Findings Primary Endpoint: CSF Leakage

DuraSeal Sealant was non-inferior compared with the control device in CSF Leakage in this study.

Of the 886 study subjects on whom data were available, 58 (6.6%) subjects (DuraSeal Exact Spine Sealant: 30 [6.6%]; Control arm: 28 [6.5%]) experienced a CSF leak within 90 days after the spine surgical procedure. The difference estimate and its 95% CI (%) between treatment arms was reported as -0.9 (- 3.7, 2.0) from an unstratified analysis and as -0.5 (-3.4, 2.3) from a stratified analysis by propensity score quintile,



Surgical Site Infections (SSI):

There was no statistically significant difference in distribution of subjects with deep Surgical Site Infection (SSI) between the treatment groups

As per CDC guideline, SSIs have been categorized into superficial SSI, DSSI, and organ/space SSI. There was a statistically significant higher proportion of subjects with superficial SSIs in the DuraSeal Exact Spine Sealant arm compared to the Control arm (2.8% versus 0.5%; p = 0.0076). Although the proportion of subjects with DSSI (2.1% versus 1.6%) and organ space SSIs (0.2% versus 0%) was numerically higher in the Control arm against the DuraSeal Exact Spine Sealant arm, the difference was not statistically significant.



Adverse Events (AEs)

There was no statistically significant difference in the proportion of subjects with any AE between the DuraSeal Exact Spine Sealant and the Control arms

Ninety-two (92) subjects experienced at least one AE (DuraSeal Exact Spine Sealant arm: 51

[10.4%] subjects; Control arm: 41 [9.4%] subjects). There was no statistically significant difference in the proportion of subjects with at least one AE between the DuraSeal Exact Spine Sealant and the Control arms (p=0.6109).

There was no statistically significant difference in the proportion of subjects with any SAE between the DuraSeal Exact Spine Sealant and the Control arms

There were 75 serious AEs reported during the study (DuraSeal Exact Spine Sealant arm: 42 [8.6%] subjects; Control arm: 33 [7.6%] subjects). There was no statistically significant difference in the proportion of subjects with at least one SAE between the DuraSeal Exact Spine Sealant and the Control arms (8.6% versus 7.6%; p=0.5755). No UADEs were reported during this study.

There was no statistically significant difference in the proportion of subjects between the treatment groups in terms of AE relatedness to the study device (p = 0.5370) and AE severity (p= 0.5979).

By relatedness, the AEs were related to the device in 22 subjects (DuraSeal Exact Spine Sealant arm: 18 subjects; Control arm: 4 subjects); There was no statistically significant difference in the proportion of subjects with definite, probable, possible, or unknown relationship/impossible to determine relatedness to the study device for AEs between the two treatments.

Final Effect Findings There was no effective endpoints, the primary and secondary endpoints are all safety related.
Study Strengths & Weaknesses Strength

Multi-center prospective treatment group with relatively large sample size so that the study is sufficiently powered and the sample is representative to the general population; Using a large number of patient with standard of care as the control arm; A pre-specified statistical plan in place to test the non-inferiority margin of 5% was in place before the study initiation.



Weakness

This is not a randomized study. The treatment group was compared with a retrospectively selected historical cohort with the standard of care. As a result, the two groups may be selected from two populations that are not exactly the same, and this may impact the result of the study.

Recommendations for Labeling Changes It is recommended that the sponsor change the conclusion regarding the risk of Surgical Site Infection to accurately reflect the PAS results.

Original language: ‘there was no statistically significant difference in distribution of subjects with any Surgical Site Infection (SSI) between the treatment groups (p=0.2295)’ New language: ‘there was no statistically significant difference in distribution of subjects with deep

Surgical Site Infection (SSI) between the treatment groups’.





OSB Lead-DuraSeal Exact Spine Sealant System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month interim report 07/06/2010 07/06/2010 On Time
1 year report 09/04/2010 11/12/2010 Overdue/Received
2 year report 09/04/2011 09/21/2011 Overdue/Received
6 month report 03/04/2012 03/02/2012 On Time
3 year report 09/03/2012 10/01/2012 Overdue/Received
4 year report 09/03/2013 09/19/2013 Overdue/Received
5 year report 09/03/2014 09/02/2014 On Time
6 year report 09/03/2015 08/20/2015 On Time
7 year report/final report 10/31/2016 10/31/2016 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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